U.S. patent application number 09/874794 was filed with the patent office on 2002-04-18 for guide wire with hydrophilically coated tip.
Invention is credited to Cornelius, Richard G., Kelzenberg, Anthony, Reynolds, Brian R., Urick, Michael J..
Application Number | 20020045885 09/874794 |
Document ID | / |
Family ID | 23423789 |
Filed Date | 2002-04-18 |
United States Patent
Application |
20020045885 |
Kind Code |
A1 |
Cornelius, Richard G. ; et
al. |
April 18, 2002 |
Guide wire with hydrophilically coated tip
Abstract
A guide wire including a lubricous distal portion and a less
lubricous intermediate portion proximal of said distal portion. One
guide wire provides a highly lubricous distal portion with a
hydrophilic layer and a less lubricous intermediate portion with a
hydrophobic layer. Another guide wire provides a lubricous distal
portion with a polymer tip that is itself hydrophilic. Yet another
guide wire provides a less lubricous intermediate portion using a
stainless steel coil helically wound around the tapering
intermediate portion. The coil is preferably coated with a
hydrophobic coating such as PTFE or silicone. The coil can either
abut the distal portion proximal end or extend into the distal
portion interior.
Inventors: |
Cornelius, Richard G.;
(Wayzata, MN) ; Kelzenberg, Anthony; (Watertown,
MN) ; Urick, Michael J.; (Rogers, MN) ;
Reynolds, Brian R.; (Ramsey, MN) |
Correspondence
Address: |
CROMPTON, SEAGER & TUFTE, LLC
Suite 895
331 Second Avenue South
Minneapolis
MN
55401-2246
US
|
Family ID: |
23423789 |
Appl. No.: |
09/874794 |
Filed: |
June 5, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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09874794 |
Jun 5, 2001 |
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09361881 |
Jul 27, 1999 |
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Current U.S.
Class: |
604/528 ;
600/585 |
Current CPC
Class: |
A61M 2025/09091
20130101; A61L 31/10 20130101; A61M 25/09 20130101; C08L 27/18
20130101; C08L 83/04 20130101; A61M 2025/09083 20130101; A61L 31/10
20130101; A61L 31/10 20130101; A61M 2025/09133 20130101; A61M
2025/09175 20130101; A61M 2025/0046 20130101 |
Class at
Publication: |
604/528 ;
600/585 |
International
Class: |
A61M 025/01 |
Claims
What is claimed is:
1. A guide wire having a distal end and a proximal end comprising:
an elongate core; a lubricous distal portion; an intermediate
portion, proximal of said distal portion, said intermediate portion
being less lubricous than said distal portion; and a proximal
portion proximal of said intermediate portion.
2. A guide wire as recited in claim 1, wherein said guide wire
includes a surface, said distal portion surface is hydrophilic, and
said intermediate portion surface is hydrophobic.
3. A guide wire as recited in claim 2, wherein said distal portion
surface includes a hydrophilic coating.
4. A guide wire as recited in claim 2, wherein said distal portion
surface includes a hydrophilic coating, and said intermediate
portion surface includes a hydrophobic coating.
5. A guide wire as recited in claim 4, wherein said proximal
portion includes a lubricous coating over said elongate core.
6. A guide wire as recited in claim 5, wherein said proximal
lubricous coating is polytetrafluoroethylene.
7. A guide wire as recited in claim 1, wherein said guide wire
includes a surface, said distal portion surface is hydrophilic, and
said intermediate portion includes a coil around said elongate
core.
8. A guide wire as recited in claim 7, said distal portion
including a polymeric distal tip having a proximally tapered
proximal portion, said coil having a distal end, wherein said coil
distal end contacts said distal tip within said tapered
portion.
9. A guide wire as recited in claim 7, wherein said intermediate
portion coil includes a hydrophobic coating.
10. A guide wire as recited in claim 9, wherein said elongate core
is tapered distally within said intermediate portion.
11. A guide wire as recited in claim 10, wherein said coil
comprises stainless steel having a silicone coating.
12. A guide wire as recited in claim 10, wherein said coil
comprises stainless steel having a polytetrafluoroethylene
coating.
13. A guide wire as recited in claim 10, wherein said coil includes
a distal tapered portion, said coil tapered portion extending
within said guide wire distal portion.
14. A guide wire having a distal end and a proximal end comprising:
an elongate core having a length and a cross section, said core
having a distal reduced cross section portion; a tapered portion
proximal of said reduced cross section portion; and a proximal
uniform cross section portion, said core having a surface extending
the length thereof, said reduced cross section portion having means
for providing low friction, said tapered portion having means for
providing higher friction than said reduced cross section portion
friction.
15. A guide wire as recited in claim 14, wherein said means for
providing higher friction includes a wire coil about said core
tapered portion.
16. A guide wire as recited in claim 15, said distal end including
a polymeric distal tip having a proximally tapered proximal
portion, said coil having a distal end, wherein said coil distal
end lies within said distal tip tapered portion.
17. A guide wire as recited in claim 15, wherein said means for
providing low friction includes a lubricous layer over said reduced
cross section portion surface, and said coil includes a less
lubricous layer over said coil.
18. A guide wire as recited in claim 14, wherein said means for
providing low friction includes a lubricous layer over said reduced
cross section portion surface; and said means for providing higher
friction includes a less lubricous layer over said tapered portion
surface.
19. A guide wire as recited in claim 18 wherein said lubricous
layer includes a hydrophilic material.
20. A guide wire as recited in claim 18, wherein said less
lubricous layer includes a hydrophobic material.
21. A guide wire having a distal end, a proximal end, a length, and
a surface extending over said length comprising: an elongate core;
a distal portion; an intermediate portion proximal of said distal
portion; means for providing low friction over said distal portion
surface; and means for providing higher friction over said
intermediate portion surface, said higher friction being higher
than said distal portion friction.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to intravascular
guide wires. In particular, the present invention relates to guide
wires having a lubricous hydrophilic tip and a less lubricous
intermediate portion proximal the distal tip.
BACKGROUND OF THE INVENTION
[0002] Guide wires are used in various procedures within various
conduits in the body. In particular, they are used in Percutaneous
Transluminal Coronary Angioplasty (PCTA) and other coronary
procedures. This can involve inserting a guide wire through an
incision in the femoral artery near the groin, advancing the guide
wire over the aortic arch, into a coronary artery, and across a
lesion to be treated. Guide wires can be inserted directly into the
vasculature or within a guide catheter. The distal end of the guide
wire ultimately lies directly within the vasculature.
[0003] Guide wires serve to guide devices into position for both
therapeutic and diagnostic purposes. For this to happen, the guide
wire itself must be properly positioned. This is difficult, as it
involves moving a wire tip through a narrow opening within a narrow
vessel, from 180 centimeters away. This task can be especially
difficult as the guide wire must be extremely flexible at the
distal end to enable the guide wire tip to enter vessel branches at
various angles. The extreme flexibility can come at the expense of
axial or rotational strength. Improved responsiveness to remotely
applied forces, both rotational and axial, has been provided by
reducing friction along the guide wire length. In particular,
providing a highly lubricous guide wire distal region of about 12
inches has proven advantageous in maneuvering guide wires through
the arteries to reach the site of blockage. Having this same
lubricous coating on the tip of the wire has been advantageous in
making the wire perform better in finding small openings in the
blockages and crossing them.
[0004] Once the guide wire tip is in position, devices including
catheters are advanced into position over the guide wire and
withdrawn over the guide wire. Such catheter movement acts upon,
and tends to move, the guide wire contained within. This can tend
to dislodge the guide wire tip. Minor patient movement including
breathing also acts to move the guide wire as does handling of the
guide wire proximal portion extending from the patient. Dislodging
the guide wire tip may require repositioning the guide wire, with
the attendant time and effort. Once in position, therefore,
stability and resistance to applied forces is preferred over the
initially desirable ease of movement and responsiveness to applied
forces.
[0005] What is desirable and has not been provided is a guide wire
easily maneuvered into position across a tight lesion, yet
providing stability and resistance to movement once the guide wire
is in position.
SUMMARY OF THE INVENTION
[0006] The present invention provides a guide wire having a highly
lubricous distal portion, followed proximally by a less lubricous
intermediate portion, followed proximally by a proximal portion.
The guide wire includes a core member within, preferably formed of
metal and having a proximal constant cross section portion,
followed distally by a tapered portion, followed distally by a
reduced cross section portion. The tapered portion can have
multiple tapers. The distal end of the reduced cross section
portion is preferably flattened into a ribbon, providing greater
flexure in one plane. A preferred core has a circular cross section
in the proximal and tapered portions. One guide wire embodiment has
a intermediate and distal portion length totalling about 12 to 14
inches. A preferred length for the distal portion is about 1 to 3
centimeters.
[0007] A preferred guide wire achieves a lubricous distal portion
by having a hydrophilic surface in the distal portion. A less
lubricous intermediate portion is achieved by having a hydrophobic
surface in the intermediate portion. The hydrophilic surface has a
very low coefficient of friction when placed against an artery wall
in a blood filled artery. The hydrophobic surface has a higher
coefficient of friction against the artery wall.
[0008] The present invention distal portion can be formed of a
polymer not necessarily hydrophilic, but having a hydrophilic
coating thereover. The intermediate portion can be formed of a
hydrophobic polymer sleeve over the core wire or a polymer sleeve
over the core wire having a hydrophobic coating. In another
embodiment, the intermediate portion can include a coil around the
core wire, the coil preferably having a hydrophobic coating. The
coil wire abuts the distal portion in one embodiment, and is
embedded beneath the distal polymer in another embodiment. In yet
another embodiment, the distal portion includes a distal tip having
a proximally tapered proximal portion, and the coil wire distal end
contacts the distal tip in the tapered portion, thereby centering
the coil.
[0009] The present invention provides the ability to cross tight
lesions by having a highly lubricous, low friction, distal portion,
which is relatively easy to slide through a narrowed vessel region.
The extremely lubricous portion is limited to a shorter length
relative to previous devices. A preferred length is about 1 inch.
The lubricity is limited to the portion where the extreme lubricity
is most needed, the distal portion. Lower friction is required in
the extreme distal portion because the core member there is
narrower and therefore weaker, not having the strength of the more
proximal portion to handle being axially pushed from the proximal
end against obstructions. Low friction is also required in this
portion because this is the portion that is required to initially
cross an extremely tight lesion, something not required of the more
proximal portion. The low friction facilitates the wire tip first
piloting into the small remaining opening in the lesion and then
crossing the lesion without buckling the wire.
[0010] To counteract the highly lubricous, low friction distal
portion, the present invention deliberately provides a less
lubricous, higher friction intermediate portion, proximal of the
distal portion. The intermediate portion can lie against an artery
wall, or guide catheter wall, "anchoring" the guide wire. The
present invention, by having an anchoring portion proximal of the
distal portion, provides resistance to forces such as catheter
movement over the guide wire, which could act to dislodge the guide
wire tip from its desired position.
[0011] While the anchoring portion friction will not prevent all
movement of the guide wire, it provides sufficient static friction
to resist unintentional movement due to either catheter movement or
patient movement. In this way, a series of minor forces acting on
the guide wire proximal portion, if below the threshold of static
friction presented by the anchoring portion, will not be translated
into a series of minor movements of the guide wire distal tip.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a fragmentary, side cross-sectional view of a
guide wire, in accordance with the present invention, having a coil
in the intermediate portion;
[0013] FIG. 2 is a fragmentary, side cross-sectional view of a
second embodiment of a guide wire having a core wire shown in
phantom;
[0014] FIG. 3 is a fragmentary, side cross-sectional view of a
third embodiment of a guide wire having a coil extending into the
distal tip;
[0015] FIG. 4 is a fragmentary, side cross-sectional view of a
fourth embodiment of a guide wire having a two part coil extending
into the distal tip; and
[0016] FIG. 5 is a fragmentary side cross-sectional view of a fifth
embodiment of a guide wire having a proximally tapered polymer tip
and a coil sitting on the taper.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017] FIG. 1 illustrates a fragmentary, side cross-sectional view
of a guide wire 20 having a distal portion 22, an intermediate
portion 24, and a proximal portion 26. Guide wire 20 has a surface
extending the length thereof, as indicated at 21. The length of
distal portion 22 is indicated by arrows 40 and the length of
intermediate portion 24 by arrows 44. Guide wire 20 includes an
elongate core member 28 having a constant cross section portion 30,
a tapered portion 32 and a reduced cross section portion 34. Core
member 28 preferably has a circular cross section in portions 30
and 32. The intermediate tapered portion 32 may comprise a single
taper or a series of tapers with regions of constant diameter in
between. Core 28 is preferably formed from high tensile strength
stainless steel wire or a super-elastic alloy such as Nitinol.
[0018] Core reduced cross section portion 34, illustrated lying
within a distal portion 22, provides extreme flexibility to the
guide wire where needed, at the extreme distal end. Reduced cross
section portion 34 is preferably flatter in one dimension than
another, forming a ribbon, providing more flexibility in one
dimension than another. Tip flexibility is desirable for
insinuating the guide wire into ever more distal and tortuous
coronary arteries. The embodiment of distal portion 22 illustrated
can include a distal tip 38 encasing core reduced cross section
portion 34. In a preferred embodiment, distal tip 38 includes a
polymeric material. Distal tip 38 is preferably radiopaque to allow
for tracking the tip position using fluoroscopy. In one embodiment,
tip 38 includes polyurethane and is loaded with tungsten, 85 to 90
percent by weight, for radiopacity. In one embodiment, a
polyurethane sleeve forms distal tip 38, which can be between about
1/2 and 7 centimeters in length. In a preferred embodiment, tip 38
is between 1 and 3 centimeters in length.
[0019] Distal portion 22 according to the present invention is
lubricous. In a preferred embodiment, distal portion 22 is
extremely lubricous. In one embodiment, the lubricity is provided
by having a hydrophilic material at the surface of distal portion
22. A hydrophilic surface makes the surface highly lubricous when
in contact with a water based fluid such as blood. In the
embodiment illustrated in FIG. 1, lubricity is provided by a distal
layer 36 over reduced diameter portion 34 and distal tip 38. A
hydrophilic coating over the guide wire presents very little
friction when sliding through the artery interior. This provides
ease of crossing tight lesions, allowing difficult and distally
remote lesions to be treated. In one embodiment, distal layer 38
includes a polyvinylpyrrolidone (PVP) coating. In another
embodiment, distal layer 38 includes a polyethyl maleic anhydride
coating. In a preferred embodiment, distal portion 22 is about
0.014 inches in diameter.
[0020] Proximal of distal portion 22 is intermediate portion 24
which has a lubricity less than that of distal portion 22. In a
preferred embodiment, intermediate portion 24 has length 44 of
about 20 to about 30 centimeters. In one embodiment, intermediate
portion 24 is about 28 centimeters long and about 0.0130 to 0.0135
inches in diameter. Guide wires used to deliver stiffer devices may
have a shorter intermediate region to make the wire more
supportive. In these cases intermediate portion 24 may be as short
as 3 centimeters. In the embodiment depicted in FIG. 1,
intermediate portion 24 includes tapered core portion 32 which is
encased in a coil 42. A preferred coil is formed of stainless steel
and coated with hydrophobic coating. A preferred hydrophobic
coating is PTFE or silicone. Coil 42, by presenting a series of
wires oriented transversely to the axial direction of guide wire
movement, provides resistance to axial movement. The coil also
provides increased pushability and kink resistance for tapered core
portion 32. In compression, the coil provides axial strength over
the length of tapered core portion 32 which decreases in strength
with decreasing core cross section. The distal end of coil 42 can
be attached to core 28 using solder or adhesive. The proximal end
of coil 28 is preferably secured to core 28 by adhesive.
[0021] Intermediate portion 24 provides a higher friction anchoring
portion to maintain the position of distal portion 22. If too much
of the guide wire is extremely lubricous, the distal tip can be
difficult to fix exactly in position, as catheter advancement and
retraction over the guide wire can apply forces to the guide wire,
tending to move the guide wire tip. Patient movement, including
breathing, can also translate into movement at the guide wire
distal tip. By providing an intermediate region having a less
lubricous surface, an intermediate anchoring region is provided,
which presents friction against the vessel wall, presenting
resistance to forces that would otherwise be translated into
movement at the distal tip. While the intermediate anchoring
portion cannot resist all forces applied to the guide wire and
prevent all tip movement, the static friction of the anchored guide
wire intermediate portion does provide a threshold barrier to lower
level forces. Thus, a series of small forces is not necessarily
translated into a series of low level movements of the guide wire
tip.
[0022] Proximal portion 26 in a preferred embodiment, extends to
the guide wire proximal end. Included in proximal portion in FIG. 1
is constant cross section core portion 30. In a preferred
embodiment, proximal portion 26 includes a stainless steel wire
about 0.013 inches in diameter and has a polytetrafluoroethylene
(PTFE) coating. In one embodiment, proximal portion 26 is less
lubricous than intermediate portion 24. In another embodiment,
proximal portion 26 is more lubricous than intermediate portion 24
but less lubricous than distal portion 22.
[0023] FIG. 2 illustrates another embodiment of the invention,
guide wire 120, having a proximal portion 126, an intermediate
portion 124, and a distal portion 122. Distal portion 122 is
preferably about 1/2 to 7 centimeters in length, and intermediate
portion 124 can be 1 to 15 inches in length and is preferably about
8 to 12 inches in length. Within guide wire 120 is a core 128
having a constant diameter portion 130, a tapered portion 132 and a
reduced diameter portion 134. Core 128 can be substantially similar
to core 28 discussed with respect to FIG. 1. Guide wire 120 has a
lubricous distal portion 122 and a less lubricous intermediate
portion 124. In the embodiment depicted in FIG. 2, distal portion
122 includes a distal tip 136. Distal tip 136 can be similar to
distal tip 36 in FIG. 1. In some embodiments, distal tip 136 is
formed of polyurethane, and coated with hydrophilic coatings as
discussed above with respect to FIG. 1. Distal tip 136 is
preferably radiopaque to allow for tracking the tip position using
fluoroscopy. In one embodiment, tip 136 includes polyurethane and
is loaded with tungsten, 85 to 90 percent by weight, for
radiopacity. Distal tip 136 is preferably more radiopaque than
intermediate portion 124.
[0024] Intermediate portion 124 provides a less lubricous portion
proximal to lubricous distal portion 122, as in the embodiment of
FIG. 1, but without requiring a coil. The lower lubricity is
provided by having a hydrophobic surface. This can be provided with
both hydrophobic sleeves and hydrophobic coatings over sleeves that
are not necessarily hydrophobic. Sleeve 142, illustrated encasing
tapered core portion 132, can be formed of a hydrophobic polymer.
Hydrophobic polymers include fluorinatedethylenepropylene (FEP) and
polytetrafluoroethylene (PTFE). Intermediate portion 124 can also
be formed of a material such as polyether block amide (PEBAX) or
polyethylene coated with a low friction, hydrophobic coating such
as silicone, paralene, PTFE, or FEP. Guide wire 120 can be formed
by sleeving tube 142 over core 128, bonding the tube in place at
its proximal end with adhesive, shrinking a suitable distal tip
material over reduced diameter core portion 134, and bonding the
distal portion of sleeve 142 to the proximal portion of the distal
tip. Another suitable method includes heat shrinking a polymeric
tube over core 128, grinding the tube to an approximate diameter of
about 0.0130 to 0.0135 inches, then selectively coating
intermediate portion 124 and possibly distal portion 122 also, with
one of the hydrophobic coatings, and then coating distal portion
122 with one of the previously described hydrophilic coatings.
[0025] FIG. 3 illustrates yet another embodiment of the invention,
a guide wire 220, having proximal portion 226 followed distally by
intermediate portion 224 followed distally by distal portion 222. A
core 228 proceeds distally from a constant diameter portion 230 to
a tapered portion 232 to a reduced diameter portion 234.
Intermediate portion 224 includes a coil 242 surrounding the
tapered portion of the core, with coil 242 proceeding distally from
a constant diameter portion 241 to a tapered portion 243 to a
reduced diameter portion 244. Core 228 is preferably flattened into
a ribbon shape in reduced diameter portion 244. Reduced diameter
portion 244 is embedded within distal tip 238 when the polymer tip
is shrunk onto the wire. In this embodiment, neither solder nor
adhesive are required to secure the distal end of coil 242 to core
228. The proximal end of coil 242 can be secured to core 228 by
soldering. Distal tip 238 can be coated with a hydrophilic layer
236 as discussed above with respect to the embodiment of FIG. 1.
The materials of distal tip 238 and layer 236 can be similar to
those of distal tip 38 and layer 36.
[0026] FIG. 4 illustrates yet another embodiment of the invention,
a guide wire 320, having a proximal portion 326, followed by an
intermediate portion 324, followed distally by a distal portion
322. A core 328 proceeds distally from a constant diameter portion
330 to a tapered portion 332, to a reduced diameter portion 334. A
coil 342 surrounds core 328 over the intermediate and distal
portions. In the embodiment shown, coil 342 is formed of a proximal
coil 323 and a distal coil 325 soldered together at 340. Proximal
coil 323 is preferably formed from a less radiopaque material such
as stainless steel. This coil can be coated with a hydrophobic
coating such as PTFE. Distal coil 325 is preferably formed of a
more radiopaque material such as platinum. Combined coil 342 is
attached to core 328 proximally with solder at 341 and distally
with either solder or welding at 338. A hydrophilic coating 336 is
applied to the distal portion of distal coil 325 in one embodiment
by first applying a Tie layer polymer such as polyurethane by dip
or spray coating, followed by applying a hydrophilic coating over
the Tie layer coating. The hydrophilic coating can be one of the
coatings described previously with respect to guide wire 20 in FIG.
1.
[0027] FIG. 5 illustrates yet another embodiment of the invention,
a guide wire 420 having a proximal portion 426, followed by an
intermediate portion 424, followed distally by a distal portion
422. A core 428 proceeds distally from a contact diameter portion
430 to a tapered portion 432, to a reduced diameter portion 434. A
distal tip 436, preferably formed of a polymeric substance,
surrounds core reduced diameter distal portion 434. Distal tip 436
includes a tapered portion 437, which tapers proximally toward core
tapered portion 432. Guide wire 420 includes a coil 442 which
extends distally over core tapered portion 432. Coil 442 has a
distal end 443 which contacts and terminates within distal tip
tapered portion 437. Coil 442 is thus always centered on core 428,
as transverse movement of coil distal end 443 is opposed by distal
tip tapered portion 437. Tip 436 can be heated to embed end 443
therein.
[0028] While use of the present invention can be described with
reference to any of the embodiments, the embodiment of FIG. 1 is
selected for further illustration. In use, core reduced diameter
portion 34 can be bent by the treating physician, prior to
insertion into the patient. Having a bent distal tip allows
orienting the tip for insertion into arteries by rotating the
proximal end of the guide wire, which rotates the bent distal tip
toward arterial side branches. The guide wire can be advanced
through a guide catheter or directly through the vasculature. After
having advanced the guide wire into a coronary artery such as the
left coronary artery, the guide wire is maneuvered into selected
smaller arteries. In attempting to insinuate the distal most
portion of the guide wire into smaller arteries, the lubricous tip
provides easier initial advancement into the artery. When a lesion
is to be crossed, lubricous distal portion 22 provides low
resistance to axial movement into and through a narrow passage. Low
resistance is advantageous as there is less tendency for core
reduced diameter portion 34 to kink or buckle when pushed by the
treating physician from the extreme proximal end.
[0029] Once distal portion 22 is across the lesion, it is highly
preferred that the guide wire tip position not change, despite
minor changes in proximal handling of the guide wire, movement of
other devices over the guide wire, patient breathing, blood flow,
and minor changes in frictional conditions along the guide wire
length. The present invention allows a guide wire to resist these
forces by having intermediate portion 24 lie against and be
"anchored" to the vessel or guide catheter wall, presenting a
higher quantity of static friction that must be overcome to
dislodge the guide wire distal tip, than presented with wires
having longer lubricous distal surfaces. The present invention thus
makes it less likely that the guide wire will move inside the
artery unless the physician is directly intending to move it.
[0030] The combination of lubricous distal portion and less
lubricous intermediate portion thus serves to promote ease of
distal tip advancement across tight lesions while stabilizing the
distal tip position once placed, allowing other devices to be
accurately guided into position by the guide wire.
[0031] Numerous advantages of the invention covered by this
document have been set forth in the foregoing description. It will
be understood, however, that this disclosure is, in many respects,
only illustrative. Changes may be made in details, particularly in
matters of shape, size, and arrangement of parts without exceeding
the scope of the invention. The inventions's scope is, of course,
defined in the language in which the appended claims are
expressed.
* * * * *